Search form

Search form

The FDA has granted ImpediMed approval to market its L-Dex U400 device for use in assessing lymphoedema, a condition that affects women who underwent surgery for breast cancer. The clearance will grant the Australian firm access to the $4.4 billion international market for lymphoedema therapies.

Related Summaries

A private placement has brought in about $56.6 million for ImpediMed. The proceeds will be used to expand sales and marketing of the Australian company's L-Dex unilateral lymphedema assessment system, as well as to strengthen its balance sheet and support its plans in the chronic heart failure business.

The American Medical Association has issued a code expanding reimbursement coverage for Impedimed's device used to detect lymphoedema, a cancer-related swelling condition. The code applies to use of the device in diagnosing lymphoedema in patients with any type of cancer, not just breast tumors. Impedimed has operations in California and Brisbane, Australia.

Device firm Impedimed is expected to benefit from the North Carolina regulation that starting Jan. 1 would require health insurers to pay physicians who screen breast cancer patients for lymphoedema. Impedimed manufactures L-Dex system, which is the only device cleared by the FDA for use in early detection of the condition.

Medivent International has secured marketing approval from the FDA for its Hayek RTX ventilator, which fits on a patient like padded body armor and externally supports natural inhalation and exhalation. The device can be used as an alternative to standard ventilators for asthma, pneumonia and other conditions.